Approval has been rejected for the use of the compound edaravone to treat motor neurone disease in Norway.
Norwegian authorities reject new motor neurone disease medicine
The medicine was assessed by the National System for Managed Introduction of New Health Technologies within the Specialist Health Service in Norway (Nye Metoder, NM) on Monday, news agency NTB reports via media Vårt Land - writes thelocal.no
“We will not be introducing edaravone as a treatment option because it has an uncertain and likely small effect,” the authority’s CEO Stig A. Slørdahl told Dagens Medicin .
Motor neurone disease, also known as amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease, is a serious disease that causes the death of neurons controlling voluntary muscles.
Many patients develop cognitive as well as physical symptoms. The cause of the disease is not fully understood.
Edaravone protects nerve cells from damage by a form of particle known as free radicals. Studies show that this can slow the progression of the disease, NTB writes.
It is yet to gain approval in Europe but has been used in the United States, Japan and South Korea.
According to the Norwegian Medicines Agency , 28 patients in Norway are currently receiving the treatment. The course of treatment is six months at a cost of one million kroner (134,000 euros) per patient.
The agency writes that only one out of three recognised medical journals, based on four various studies, concluded a positive overall effect of the drug compared to a placebo. In that conclusion, the medicine had a small effect on a subgroup of patients at an early stage of the progressive disease, NTB writes.
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